A prospective, open-labelled, comparative clinical study to evaluate the safety and efficacy of the combination therapy of Syrup PCOS001 and Capsule PCOS002 compared with standard-of-care in adult women diagnosed with poly-cystic ovarian syndrome. - NI

JAMMI PHARMACEUTICALS PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Young women of age between 18 to 40 yrs. diagnosed with PCOS
•2.Sub-fertile females
•3.Polycystic ovaries with exclusion of other aetiologies
•4.Women with normal uterine cavity
•5.Subjects with history of Impaired Glucose Tolerance or Insulin Resistance with PCOS
•6.Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, haematology, routine urinalysis and measurement of oral temperature and vital signs.

•1.Pregnant or lactating women.
•2.Subjects with presence of infertility factors other than anovulation
•3.Subjects with pelvic organic pathologies, presence of other pathologies such as non-classical congenital adrenal hyperplasia, Cushing’s syndrome and androgen secreting tumours
•4.Subjects with thyroid dysfunction, hyperprolactinemia, androgen secreting neoplasm.
•5.Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonal drugs.
•6.Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e., type 1 or type 2 diabetes, renal disease, and mal-absorptive disorders, acute and chronic inflammations) confirmed based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.
•7.Subjects with known history of hypersensitivity to the study drugs.
•8.Alcoholic consumers and smokers

发起方

JAMMI PHARMACEUTICALS PVT LTD